NCT02448381

FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Soligenix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

Conditions

• Cutaneous T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	SGX301 (synthetic hypericin)	0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.
DRUG	Placebo	USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm\^2 fluorescent light.

Timeline

• Start date: 2015-12-01
• Primary completion: 2020-06-01
• Completion: 2020-11-01
• First posted: 2015-05-19
• Last updated: 2022-04-15
• Results posted: 2022-04-15

Locations

33 sites across 1 country: United States